Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT03355118
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2017-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxygen Extraction and Delivery in Elderly During Major Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxygen consumption', 'timeFrame': 'prior to and 15 minutes after anaesthesia induction', 'description': 'change of oxygen consumption after anaesthesia induction'}], 'secondaryOutcomes': [{'measure': 'oxygen consumption', 'timeFrame': 'perioperatively 0-36hrs', 'description': 'changes of oxygen consumption during surgery and postoperative recovery'}, {'measure': 'oxygen extraction ratio', 'timeFrame': 'perioperatively 0-36hrs', 'description': 'ratio between oxygen consumption and oxygen delivery'}, {'measure': 'oxygen extraction ratio: estimated and measured', 'timeFrame': 'perioperatively 0-36hrs', 'description': 'ratio between oxygen consumption and oxygen delivery estimated from blood gases and measured by indirect calorimetry and cardiac output monitoring'}, {'measure': 'C(v-a)pCO2/C(a-v)O2', 'timeFrame': 'perioperatively 0-36hrs', 'description': 'Ratio: venoarterial pCO2 difference/arterio-venous oxygen content difference'}, {'measure': 'postoperative complications', 'timeFrame': 'postoperative days 3,5 and 10', 'description': 'postoperative complications described by Postoperative Morbidity Survey (8)'}, {'measure': 'mortality', 'timeFrame': 'postoperative days 30', 'description': 'postoperative mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impaired Oxygen Delivery', 'Surgery', 'Postoperative Complications', 'Peroperative Complication']}, 'referencesModule': {'references': [{'pmid': '32858583', 'type': 'DERIVED', 'citation': 'Jakobsson J, Noren C, Hagel E, Kalman S, Bartha E. Peri-operative oxygen consumption revisited: An observational study in elderly patients undergoing major abdominal surgery. Eur J Anaesthesiol. 2021 Jan;38(1):4-12. doi: 10.1097/EJA.0000000000001302.'}]}, 'descriptionModule': {'briefSummary': 'This clinical observational study investigates perioperative oxygen consumption and delivery in elderly patients undergoing major surgery. The primary objectives are to characterise the perioperative oxygen delivery, consumption and potential markers of oxygen debt. Secondary objective is to estimate the correlation between oxygen delivery/consumption and postoperative outcomes to guide the design of a future trial.', 'detailedDescription': 'Background Intra- and postoperative fluid therapy aims to achieve or maintain pre-specified thresholds of oxygen delivery/blood flow which can be accomplished by use of fluids with or without inotropic drugs. The used thresholds of oxygen delivery were suggested over 40 years ago, in considerably younger patients compared to the current patients. Update of the characteristics of perioperative oxygen delivery and consumption is reasonable in modern clinical settings.\n\nPrimary outcome:\n\nrelative changes of oxygen consumption induced by anaesthesia\n\nSecondary outcomes:\n\nrelative changes of oxygen consumption and delivery during surgery and postoperatively, oxygen extraction ratio (measured and estimated), potential markers of oxygen debt frequency of in-hospital postoperative complications, mortality (30 Days)\n\nPopulation:\n\nMen and women ≥65 years undergoing major/complex surgical procedures, when intra-operative cardiovascular monitoring is justified according to clinical decision.\n\nIntervention: no study related intervention, general anaesthesia and surgery according to clinical routine\n\nBlinding: no blinding\n\nStudy size:\n\nPilot study 1: feasibility assessment of study protocol of intra-operative measurements (n= max 10) Pilot study 2: feasibility assessment of study protocol of postoperative measurements (n= max 10) Main study: 60 subjects (20+´40) Planned analysis of oxygen consumption after 20 monitored subjects\n\nStudy duration:\n\nDuration of haemodynamic monitoring 24-36 hours Duration of observation of clinical outcomes: 7-10 days, mortality at 30 days postop.\n\nInvestigational events:\n\nmonitoring of oxygen consumption and delivery monitoring of postoperative clinical outcomes monitoring of markers of tissue injury\n\nAssessments, Procedures and Schedule of Investigational Events:\n\nSubjects are identified by the operation planning list and assessed for eligibility. The study information will be given verbal during the first hospital visit. Subjects who give written informed consent will be included in the study.\n\nMeasurements:\n\noxygen consumption by indirect calorimetry via face mask (in awake state) and via expiratory extension tube of anaesthesia machine (unconscious state) cardiac output monitoring via arterial line (LiDCO) blood samples: arterial and venous blood gase samples, Troponin-T urine samples: N-gal\n\nClinical outcomes:\n\nData collection from medical records on postoperative complications using the POMS (postoperative morbidity survey) screening survey at days 3,7 and 10. Postoperative mortality at day 30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women ≥65 years undergoing major/complex surgical procedures at the Karolinska University Hospital in Huddinge, Stockholm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women aged ≥65 years\n2. Major/complex surgery (BUPA AXA classification of surgical severity)\n3. Central and arterial venous catheterization for hemodynamic monitoring.\n4. Written informed consent\n5. Available research team for the measurements If two subjects are eligible the elder one will be chosen. If there are two subjects eligible of different gender and almost the same age, the subject with a gender that is underrepresented by two or more will be chosen. This is consistent with the purpose of including subjects with as high age as possible without interfering with recruitment.\n\nExclusion Criteria\n\n1. Concomitant medication with Lithium (interferes with calibration of the LiDCO monitor)\n2. Weight≤ 40 kg.\n3. Not possible to establish arterial or central venous line.\n4. Planned postoperative care at high-dependency unit (POP/IMA) \\<12hrs.'}, 'identificationModule': {'nctId': 'NCT03355118', 'briefTitle': 'Oxygen Extraction and Delivery in Elderly During Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Exploring New Grounds in Physiology of the Elderly- Oxygen Extraction and Delivery During Anaesthesia and Major Surgery', 'orgStudyIdInfo': {'id': 'K2017-0373'}, 'secondaryIdInfos': [{'id': '4-500/2017', 'type': 'OTHER', 'domain': 'Karolinska Institutet'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'General anaesthesia and major surgery', 'type': 'OTHER', 'description': 'The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome'}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Erzsebet Bartha, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska University Hospital Huddinge, Stockholm, Sweden'}, {'name': 'Julia Jakobsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital Huddinge, Stockholm, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Senior Consultant', 'investigatorFullName': 'Sigridur Kalman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}